Maa: Tansania
Kieli: englanti
Lähde: Tanzania Medicinces & Medical Devices Authority
Artesunate
Psychotropics India Limited, INDIA
Antimalarials
Artesunate
60
Solution for injection
Psychotropics India Limited, INDIA
Physical description: White to almost white powder; Local technical representative: KAS MEDICS LIMITED (9670)
Registered/Compliant
2022-12-05
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT: Brand Name: ARTEPIL Generic Name: Artesunate for Injection Ph. Int. 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: EACH VIAL CONTAINS: Artesunate (Sterile) Ph.Int 60 mg In combipack with: 1ml ampoule of Sodium Bicarbonate Injection USP 5% w/v 5ml ampoule of Sodium Chloride Injection USP 0.9 %w/v 3. PHARMACEUTICAL FORM White to almost white powder filled in 5ml clear USP type III glass vial with rubber bung aluminium seal having Taxim blue flip on top. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Artesunate Injection is an Antimalarial drug. It is indicated for the treatment of severe malaria caused by Plasmodium falciparum, in adults and children. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ _Route of administration: _ Intravenous or Intramuscular Injection Method of preparation Using a syringe, withdraw 1 ml of the sodium bicarbonate solvent from the ampoule and inject into the vial containing the artesunate powder. Shake the vial for several minutes to form a solution. Following this reconstitution, the solution must be diluted according to the route of injection, as described below: For intravenous (IV) injection: Using a syringe, add 5 ml of sodium chloride 0.9% for injection to the vial containing the reconstituted artesunate solution. This will yield 6 ml of a solution containing artesunate 10 mg/ml For intramuscular (IM) injection: Using a syringe, add 2 ml of sodium chloride 0.9% for injection to the vial containing the reconstituted artesunate solution. This will yield 3 ml of a solution containing artesunate 20 mg/ml WATER FOR INJECTION IS NOT AN APPROPRIATE DILUENTS DOSE: Paediatrics less than 20 kg: 3 mg/kg Patients above 20 kg: 2.4mg/kg NUMBER OF VIALS REQUIRED TO INITIATE A PARENTERAL DOSE 4.3 CONTRAINDICATIONS Artesunate Injection is contraindicated in patients with hypersensitivity to Artesunate or other artemisinin. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _N O N - F A L C I P A R U M _ _MALARIA _ Artes Lue koko asiakirja